Shortnacy v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

**********************

LAUREN SHORTNACY, * No. 10-827V

* Special Master Christian J. Moran

Petitioner, *

* Filed: September 15, 2014

v. *

* Decision on the record; statute of

SECRETARY OF HEALTH * limitations; insufficient

AND HUMAN SERVICES, * proof of causation; human

* papillomavirus vaccine (“HPV”);

* nodular sclerosing Hodgkin’s

Respondent. * disease.

**********************

Patricia Leigh O’Dell, Beasley, Allen, et al., Montgomery, AL, for petitioner;

Ann Martin, United States Dep’t of Justice, Washington, DC, for respondent.

PUBLISHED DECISION DENYING COMPENSATION1

Lauren Shortnacy filed a petition under the National Childhood Vaccine

Injury Act, 42 U.S.C. §300aa—10 through 34 (2006), on December 2, 2010. Ms.

Shortnacy alleges that the doses of the human papillomavirus (“HPV”) vaccine she

received on July 23, 2007, September 26, 2007, and January 28, 2008, caused her

to suffer nodular sclerosing Hodgkin’s disease (“Hodgkin’s”).

In support of her claim, Ms. Shortnacy has submitted opinions from her

experts, Michael McCabe, Ph.D., a toxicologist and immunologist, and Stephen L.

Davidson, M.D., an oncologist. Dr. McCabe provided a theory to explain how the

HPV vaccine could have caused Ms. Shortnacy’s Hodgkin’s. Dr. Davidson

provided an opinion on the onset of Ms. Shortnacy’s Hodgkin’s in response to the

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The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,

2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b),

the parties have 14 days to file a motion proposing redaction of medical information or other

information described in 42 U.S.C. § 300aa—12(d)(4). Any redactions ordered by the special

master will appear in the document posted on the website.

Secretary’s argument that the case was untimely filed and barred by the Vaccine

Act’s statute of limitations. In opposition to Ms. Shortnacy’s expert opinions, the

Secretary offered the opinion of Kenneth L. McClain, Ph.D., M.D., an oncologist.

In lieu of proceeding with a previously scheduled entitlement hearing, Ms.

Shortnacy filed a motion for a ruling on the record on July 7, 2014. For the

reasons set forth below, Ms. Shortnacy’s petition is untimely and she has not

demonstrated that she is entitled to compensation.

I. Background

A. Medical History

Ms. Shortnacy received doses of the HPV vaccine on July 23, 2007,

September 26, 2007, and January 28, 2008. On November 21, 2007, Ms.

Shortnacy went to a clinic where she reported a cough, congestion, sore throat, and

swollen lymph nodes. Ms. Shortnacy did not complain of itchiness. Findings of

Fact, issued Mar. 30, 2012, at 6.

On December 3, 2007, Ms. Shortnacy saw her pediatrician, Dr. Paris, where

she complained of swollen lymph nodes in her neck area and dry, itchy skin. Id.

By mid-December 2013, the swelling in Ms. Shortnacy’s lymph nodes decreased,

but her lymph nodes did not return to normal size. Id. at 11. After the swelling

returned, Ms. Shortnacy saw Dr. Paris on January 7, 2008, complaining of swollen

glands under her left armpit. Id. Ms. Shortnacy underwent a lymph node biopsy

and was diagnosed with Hodgkin’s on February 1, 2008. Id. at 11-12.

Ms. Shortnacy received treatment at the AFLAC Cancer Center and Blood

Disorders Service at Children’s Health Care of Atlanta and underwent six rounds

of chemotherapy by July 2008. Exhibit 5 at 324. After completing chemotherapy,

Ms. Shortnacy received treatment for intracranial hypotension and avascular

necrosis. Exhibit 10 at 3-5, 14-16, 26. By her December 14, 2010 cancer survivor

consultation, Ms. Shortnacy reported that she was doing well and studying nursing

as a sophomore in college. Id. at 44.

B. Procedural History

The events associated with the prosecution of Ms. Shortnacy’s claim are set

forth in the sections below beginning with the factual development of her case

followed by the submission of expert opinions and preparation for hearing.

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1. Factual Development

In support of her December 2, 2010 petition, Ms. Shortnacy filed medical

records (exhibits 1-10) on February 15, 2011, and March 31, 2011. Her February

15, 2011 filing also included an amended petition, changed only in marking her

exhibits as numbered rather than lettered. A status conference was held on April 6,

2011, during which respondent indicated that Ms. Shortnacy’s medical histories

suggest her symptoms began prior to December 2007. In response, Ms. Shortnacy

proposed providing an affidavit from Dr. Paris, her doctor in December 2007. Ms.

Shortnacy was ordered to submit an affidavit from herself and Dr. Paris describing

her condition before December 2007. Order, issued Apr. 6, 2011. Ms. Shortnacy

filed the affidavits (exhibits 11-12) and a report from Dr. McCabe (exhibit 13) in

early July 2011.

A status conference was held on July 11, 2011. During this conference, the

Secretary again raised her concern over the timeliness of Ms. Shortnacy’s petition

and proposed a fact hearing to resolve the onset of her symptoms. Consequently,

the parties began planning for a fact hearing.

Ms. Shortnacy filed additional records from Columbus Clinic and Acute

Care on July 19, 2011 (exhibit 14). On August 19, 2011, Ms. Shortnacy filed a

second amended petition in which she changed the characterization of her

December 3, 2007 itching from “extreme” to “mild.” Compare Pet., filed Dec. 2,

2010, ¶ 3 with 2d Am. Pet., filed Aug. 19, 2011, ¶ 3.

The Secretary assessed Ms. Shortnacy’s claim in her report and concluded

that Ms. Shortnacy was not entitled to compensation for two separate reasons.

Resp’t’s Rep., filed Aug. 26, 2011, at 2. First, notwithstanding the shift in

allegations from severe itching to mild itching, the Secretary concluded Ms.

Shortnacy was displaying symptoms of Hodgkin’s more than 36 months before she

filed her petition. As such, the statute of limitations barred Ms. Shortnacy’s

petition. Id. at 11-13.

In addition to asserting that Ms. Shortnacy’s petition was time-barred, the

Secretary also concluded that Ms. Shortnacy failed to fulfill the criteria for a

Vaccine Table injury, or demonstrate by a preponderance of the evidence her

Hodgkin’s was caused by the HPV vaccines she received. Id. at 13-16.

A status conference was held on September 1, 2011, during which the

parties discussed proceeding with a November 2011 fact hearing in light of

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respondent’s Rule 4 report. In an order issued following the conference, Ms.

Shortnacy was directed to file affidavits from herself and her mother detailing the

severity of her fatigue from July to December 2007, and whether her itching

started before December 3, 2007.

In response to the September 1, 2011 order, Ms. Shortnacy filed affidavits

(exhibit 15-21), as well as school and employment records (exhibits 19-20). The

affidavits generally described Ms. Shortnacy’s fatigue and itching as beginning in

late December 2007.

A factual hearing was held on November 1, 2011. Ms. Shortnacy, her

mother, father, Dr. Paris, and a family friend testified via videoconferencing at the

hearing. The parties completed submitting their posthearing briefs in February

2012.

On March 30, 2012, the findings of fact were issued stating that Ms.

Shortnacy was experiencing “an unusual amount” of itchiness on December 3,

2007. Findings of Fact at 7. Additionally, Ms. Shortnacy’s itchiness began prior

to her December 3, 2007 visit. Id. at 9. These findings did not resolve the date of

onset of Ms. Shortnacy’s Hodgkin’s disease.

2. Expert Opinions

As noted above, early in the case, Ms. Shortnacy filed a report from Dr.

McCabe about causation (exhibit 13). In this report, Dr. McCabe opined that Ms.

Shortnacy’s Hodgkin’s resulted from stimulation of her immune system by Virus-

Like Particles (“VLPs”) and the alum adjuvant contained in the HPV vaccine.

Exhibit 13 at 5-8. Dr. McCabe concluded that the VLPs and adjuvant “promoted a

favorable microenvironment… that promoted malignant transformation and/or

survival of HRS cells thereby leading to [Ms.] Shortnacy's Hodgkin's lymphoma.”

Id. at 7.2 Dr. McCabe additionally opined that it was reasonable to expect that the

immune response generated by the HPV vaccine also transformed HRS cell

precursors harboring latent Epstein-Barr virus (“EBV”) into malignancies.3

2

HRS, or Hodgkin Reed Sternberg, cells are a common histologic characteristic of

Hodgkin’s disease. Dorland’s Illustrated Medical Dictionary 322 (32nd ed. 2012).

3

Dr. McCabe cited to Ms. Shortnacy’s medical records documenting antibody reactivity

to EBV and varicella zoster. Exhibit 13 at 2 (discussing exhibit 7 at 23).

4

Following an April 19, 2012 status conference, Ms. Shortnacy was ordered

to file an expert report by July 18, 2012. Since Dr. McCabe is not a medical

doctor, he lacked the qualifications to discuss when a disease began. Thus, Ms.

Shortnacy needed to find a new expert. Order, issued Apr. 19, 2012. After three

extensions of time, Ms. Shortnacy filed her report from Dr. Davidson on

November 12, 2012 (exhibit 26).

In his report, Dr. Davidson stated that “my honest assessment is that Lauren

likely systemically developed Hodgkin's disease prior to November 2007” and that,

in his opinion, “the first clearly established symptoms and manifestations of the

onset of the disease” was in early January 2008. Exhibit 26 at 3.

A status conference was held on January 30, 2013, during which the

Secretary raised again the issue of timeliness and requested a supplemental report

from Dr. Davidson regarding symptom onset. Ms. Shortnacy was ordered to file a

supplemental report as the Secretary requested. Order, issued Jan. 31, 2013. For

this report, Ms. Shortnacy was instructed to have Dr. Davidson address the

undersigned’s March 30, 2012 Findings of Fact and to clarify whether Ms.

Shortnacy’s December 3, 2007 symptoms (swollen lymph nodes and dry, itchy

skin) were manifestations of the onset of her Hodgkin’s disease. Id.

In his supplemental report (exhibit 28, filed Feb. 26, 2013), Dr. Davidson

maintained that Ms. Shortnacy’s early January 2008 symptoms, not her December

3, 2007 symptoms, were the first onset symptoms of her Hodgkin’s disease.

Exhibit 28 at 1.

During a status conference held on March 5, 2013, the Secretary stated that

she intended to file a report from Dr. McClain, an oncologist, responding to Dr.

Davidson’s onset opinion. Ms. Shortnacy was ordered to provide this report to Dr.

Davidson and report his initial impressions at the next status conference. Order,

issued Mar. 5, 2013.

On April 16, 2013, the Secretary filed the report on onset from Dr. McClain

(exhibit B). In his report, Dr. McClain concluded that “the lymphadenopathy and

pruritus present on 12-3-2007 were most likely symptoms of Hodgkin lymphoma.”

Exhibit B at 2.

During the status conference following Dr. McClain’s report, the Secretary

stated that bifurcating the statute of limitations issue from the causation issue was

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not necessary. The Secretary offered to file a report from Dr. McClain on the issue

of causation. Order, issued May 2, 2013.

In his second report (exhibit E, dated June 19, 2013), Dr. McClain strongly

opposed Dr. McCabe’s immune stimulation theory. Dr. McClain opined that while

immune stimulating cells surrounding pathologic HRS cells do impact their

survival, this is secondary to the primary cause of Hodgkin’s: multiple genetic

mutations in key cell signaling pathways. Exhibit E at 1. Dr. McClain disagreed

with Dr. McCabe’s opinion that immunizations prompt the production of signals

from immune cells that can cause Hodgkin’s. Rather, Dr. McClain stated that the

multiple genetic mutations that cause Hodgkin’s also paralyze the very same

immune system signaling on which Dr. McCabe relied. Furthermore, Dr. McClain

indicated that Dr. McCabe’s HRS cell proliferation theory was not genetically

possible given the fact that HRS cells do not possess functional versions of the

necessary genes. Id. at 3.

Dr. McClain cited to literature for evidence that EBV’s role in stimulating

HRS cell malignancies is secondary to genetic events that occur prior to viral

infection. Id. (citing exhibit X (Enrico Tiacci et al., Analyzing primary Hodgkin

and Reed-Sternberg cells to capture the molecular and cellular pathogenesis of

classical Hodgkin lymphoma, 120(23) Blood 4609 (2012)). Moreover, Dr.

McClain stated that although Ms. Shortnacy’s records indicate a past EBV

infection, there was no evidence for assuming that EBV had a role in causing her

Hodgkin’s without Epstein-Barr Encoded RNA (“EBER”) staining of her lymph

node biopsy to document the presence of EBV in her HRS cells.

In response to Dr. McClain’s report, Ms. Shortnacy was ordered to file a

responsive report from Dr. McCabe as well as a status report on the availability of

a pathology sample for EBER staining. Order, issued July 16, 2013. Ms.

Shortnacy reported that she had ordered the requested pathology slides and

arranged for their storage. Pet’r’s Status Rep., filed Aug 28, 2013.

On August 30, 2013, Ms. Shortnacy filed a supplemental report from Dr.

McCabe (exhibit 33) in which he argued that Dr. McClain had mischaracterized his

immune stimulation theory. Exhibit 33 at 2. Dr. McCabe clarified that he did not

suggest that the HPV vaccine could cause Hodgkin’s by giving rise to B cell

mutation. Id. Dr. McCabe asserted that Dr. McClain ignored “a large body of

research and scientific consensus that inflammation is a promoter in the process of

carcinogenesis[,]” but provided no citation to such research. Id. at 2. Dr. McCabe

then restated his theory that Ms. Shortnacy’s Hodgkin’s was caused by an HPV

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vaccine-elicited immune response which triggered malignancy in HRS precursor

cells. Dr. McCabe cited studies by Frazer and Pinto et al. as evidence of the

immune response elicited by HPV vaccination. Id. at 3 (citing exhibit 34 (Ian

Frazer, Correlating immunity with protection for HPV infection, 11 (Supp. 2) Int’l

J. Infectious Diseases S10 (2007); exhibit 35 (Ligia A. Pinto et al., HPV-16 L1

VLP vaccine elicits a broad-spectrum of cytokine responses in whole blood, 23

Vaccine 3555 (2005)).

On November 21, 2013, the Secretary filed a supplemental report from Dr.

McClain (exhibit BB) responding to Dr. McCabe (exhibit 33). In this report, Dr.

McClain asserts that Dr. McCabe’s theory in which a potent vaccine response

causes growth of lymphomas is “not scientifically reliable.” Exhibit BB at 1. Dr.

McClain also reviewed the literature cited by Dr. McCabe and provided

interpretations contradicting those of Dr. McCabe. In particular, Dr. McClain

found that the Pinto et al. study (exhibit 35), which Dr. McClain cited as evidence

of an “active and ongoing” immune response following HPV vaccination, actually

supports the opposite conclusion that immune responsive cells are in fact not

continuously active.

Dr. McClain concluded that:

Ms. Shortnacy had a mutation in a germinal center B cell that became

a Hodgkin Lymphoma cell. It activated the immune cells around it

which supported the malignant cell with cytokines and chemokines[;]

the malignant cells grew, migrated, and caused her Stage IIIA

Hodgkin Lymphoma. [The HPV] immunization had nothing to do

with this process[;] it was merely coincidental.

Exhibit BB at 3.

Ms. Shortnacy was ordered to file the EBER staining results as well as a

status report indicating if Dr. McCabe would be filing a response to Dr. McClain.

See order, issued Jan. 16, 2014. Ms. Shortnacy reported that an additional report

from Dr. McCabe would not be helpful. Pet’r’s Rep., filed Jan. 27, 2014. On

February 12, 2014, Ms. Shortnacy filed a status report seeking “the Court’s

assistance in discussing additional avenues for mediation.” Pet’r’s Rep., filed Feb.

12, 2014.

Ms. Shortnacy filed the EBER test results (exhibit 42) on February 18, 2014.

During a status conference held later that same date, the parties agreed to file

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supplemental expert reports in light of the negative EBER results. Additionally,

the parties discussed Ms. Shortnacy’s request for mediation, to which respondent

stated that she did not believe mediation would be productive considering

petitioner’s claim. Order, issued Feb. 19, 2014.

On March 4, 2014, the Secretary filed another supplemental report from Dr.

McClain (exhibit EE) stating that the negative EBER result nullified Dr. McCabe’s

theory. Exhibit EE at 1 (discussing Dr. McCabe’s report, exhibit 13 at 5). On

March 21, 2014, Ms. Shortnacy filed a supplemental report from Dr. McCabe

(exhibit 43) stating that the negative EBER result had no effect on his theory as it

was never contingent on the presence of Epstein-Barr virus. Exhibit 43 at 1-2.

3. Preparation for Hearing

Pursuant to an earlier order, the hearing was set for June 19-20, 2014.

Order, issued Oct. 9, 2013. The parties were ordered to file prehearing briefs in

preparation for hearing. Order, issued Apr. 4, 2014. In this order for prehearing

briefs, the undersigned detailed the issues of Ms. Shortnacy’s case in regard to

timeliness and the Althen prongs and directed the parties to address these issues in

their briefs. The parties were directed to confirm that each of their experts had

completely disclosed their opinions before the hearing, and to inform the court if

additional supplemental reports were required. Id. The parties submitted their

briefs by the end of May 2014.

On June 2, 2014, the undersigned issued an order stating that upon his

review of the case material, including the parties’ prehearing briefs, he had reached

a tentative conclusion that petitioner was unlikely to prevail on either the

timeliness of her petition or that the HPV vaccine caused her Hodgkin’s. The

undersigned discussed the weaknesses of Ms. Shortnacy’s case including the

disparity between the qualifications of the testifying witnesses. In light of the

problems with Ms. Shortnacy’s case, the undersigned expressed the concern that

proceeding to a hearing might lack reasonable basis.

By the June 10, 2014 prehearing status conference, the hearing schedule had

been slightly amended to accommodate Ms. Shortnacy’s expert, Dr. Davidson.4 At

that status conference, Ms. Shortnacy proposed that the undersigned provide a

4

Dr. Davidson was no longer able to testify on June 19-20, 2014, due to an unavoidable

conflict.

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decision on the statute of limitations issue before proceeding with a causation

hearing. Additionally, Ms. Shortnacy acknowledged the difference in credentials

between Dr. McCabe and Dr. McClain and stated that she may wish to retain an

oncologist to opine on causation.

The Secretary opposed Ms. Shortnacy’s proposal to retain an oncologist and

stated that the difference between Dr. McClain’s and Dr. McCabe’s qualifications

was not new and that considerable time and resources had already been invested in

prosecuting Ms. Shortnacy’s claim. Ms. Shortnacy requested the remainder of the

day to consider whether to proceed with the hearing.

A follow-up status conference was held the next day. At this conference,

Ms. Shortnacy confirmed that she did not want to proceed with the scheduled

hearing and instead intended to file a motion for a ruling on the record. The

Secretary did not object. See order, issued June 11, 2014.

On June 25, 2014, Ms. Shortnacy moved for a decision on the written

record. In her motion, Ms. Shortnacy states that although she is able to

demonstrate causation for her Hodgkin’s, she “has decided not to move forward

with a hearing.” Pet’r’s Mot., filed June 25, 2014, at 8.

Respondent filed a response stating “[a] preponderance of the evidence does

not support a finding that petitioner’s case was timely filed. Even assuming

arguendo that petitioner’s case were timely filed, there is not a preponderance of

reliable scientific evidence to support a finding that petitioner’s HPV vaccine(s)

caused the development of her Hodgkin’s Lymphoma.” Resp’t’s Resp., filed July

7, 2014, at 18. Ms. Shortnacy did not file a reply to respondent’s response.

Accordingly, this case is now ready for adjudication.

II. Ruling on the Record

In establishing the Vaccine Program, Congress instructed the Court of

Federal Claims to promulgate rules, including a rule for “the opportunity for

parties to submit . . . evidence on the record without requiring routine use of oral

presentations, cross examinations, or hearings.” 42 U.S.C. § 300aa—12(d)(2)(D).

In accord with this statutory directive, “the special master may decide a case on the

basis of written submissions without conducting an evidentiary hearing.” Vaccine

Rule 8(d).

9

The Court of Federal Claims has interpreted Congress’ intent as not

requiring routine oral presentations, but rather that interested parties be afforded

only the opportunity to submit relevant written information. Hale v. Sec’y of

Health & Human Servs., 22 Cl. Ct. 403, 407 (1991). Furthermore, the Vaccine

Program was designed to “avoid hearings and dispose of cases quickly.” Boley v.

Sec’y of Health & Human Servs., 05-420V, 2008 WL 4615034, at *2 (Fed. Cl.

Sept. 9, 2008), mot. for rev. denied, 86 Fed. Cl. 294 (2009).

Although a hearing was scheduled, Ms. Shortnacy stated that she did not

want to proceed to trial and moved for a ruling on the record. Pet’r’s Mot., filed

June 25, 2014. The parties have had an opportunity to present their cases and the

record is adequate for making a decision.

The procedural posture of the case is that of a ruling on the record, not a

motion for summary judgment. As such, Ms. Shortnacy is not entitled to

inferences in her favor. She must establish her case by preponderant evidence.

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir.

2010). Ms. Shortnacy’s claim for compensation is discussed below beginning with

the timeliness of her petition, followed by a causation analysis.

III. Statute of Limitations

A living petitioner has 36 months to file a petition for compensation from

the first symptom or manifestation of onset of an injury. 42 U.S.C. §300aa—

16(a)(2) (2006). The statute of limitations can be triggered by either a symptom of

the injury or a manifestation of onset, “whichever is first.” Markovich v. Sec’y of

Health & Human Servs., 477 F.3d 1353, 1357 (Fed. Cir. 2007).

The day of onset is excluded in calculating the statute of limitations and

accrual begins the following day. Spohn v. Sec’y of Health & Human Servs., No.

95-0460V, 1996 WL 532610, at *3 (Fed. Cl. Spec. Mstr. Sept. 5, 1996)

(determining the statute of limitations for claim based upon symptoms starting July

17, 1992, expired on July 17, 1995, and dismissing petition based upon a filing one

day after the expiration of the statute of limitations), mot. for rev. denied in

unpublished op. (Fed. Cl. Jan. 10, 1997), aff’d, 132 F.3d 52 (Fed. Cir. 1997)

(table). Ms. Shortnacy filed her petition on December 2, 2010. In order for Ms.

Shortnacy to have filed her petition within the statute of limitations, the first

manifestation of onset must have occurred on or after December 2, 2007.

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The medical field must recognize the symptom or manifestation of onset as

part of the condition for which compensation is sought. Cloer v. Sec’y of Health &

Human Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011) (en banc), cert. denied, 132

S.Ct. 1908 (2012). At least two symptoms could be viewed as heralding the onset

of Ms. Shortnacy’s Hodgkin’s. These are swollen lymph nodes and itchiness.

Exhibit B at 2-3; exhibit 26 at 2.

Ms. Shortnacy’s expert, Dr. Davidson, acknowledged that she “likely

systemically developed Hodgkin's disease prior to November 2007.” Exhibit 26 at

3. Dr. Davidson opined that the upper respiratory infection Ms. Shortnacy suffered

in November 2007, was likely a result of her immune system being compromised

by Hodgkin’s disease. Id. However, Dr. Davidson argues that Ms. Shortnacy’s

Hodgkin’s was not “clinically apparent” until early January 2008, when her

bloodwork showed atypical lymphocytes and her lymph nodes enlarged for the

second time in association with pruritus and fatigue. Exhibit 26 at 3; exhibit 28

at 1.

In light of his opinion that Ms. Shortnacy’s disease likely began before

November 2007, Dr. Davidson’s opinion regarding Ms. Shortnacy’s swollen

lymph nodes is unclear. Ms. Shortnacy was observed to have swollen lymph nodes

on November 21, 2007, and December 3, 2007. Exhibit 14 at 4; exhibit 2 at 62.

Despite opining that her November 2007 infection was likely due to her

Hodgkin’s, Dr. Davidson maintains that Ms. Shortnacy’s symptoms on November

21, 2007, were consistent with an infectious process and that her Hodgkin’s was

not clinically apparent. Exhibit 26 at 3. Dr. Davidson does not dismiss Ms.

Shortnacy’s swollen nodes on December 3, 2007, but instead states that her

symptoms of January 2008 were “more clinically apparent” for diagnosing

Hodgkin’s. Id. Dr. Davidson finds the swelling significant only in January 2008,

when the swollen lymph nodes were also present in the axilla and they were

accompanied by bloodwork showing atypical lymphocytes. Id.; exhibit 2 at 50-52;

exhibit 3 at 4. Although Dr. Davidson provides some basis for not accepting Ms.

Shortnacy’s November and December 2007 swollen nodes as the onset of her

Hodgkin’s, he does not provide a basis for dismissing her December 2007

itchiness. See exhibit 26; see also exhibit 28.

Dr. Davidson’s silence regarding Ms. Shortnacy’s early December 2007

itchiness is a weakness. It is difficult to follow Dr. Davidson’s reasoning that Ms.

Shortnacy’s disease began prior to November 2007, but was not clinically apparent

until January 2008, despite complaints of similar symptoms in the two previous

months.

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On the other hand, the Secretary’s expert, Dr. McClain, opined that Ms.

Shortnacy’s itchiness and swollen lymph nodes on December 3, 2007, were most

likely symptoms of Hodgkin’s. Exhibit B at 2. Dr. McClain cited to literature

underscoring the importance of pruritus in diagnosing Hodgkin’s. Id. (citing

exhibit D (Paolo G. Gobbi et al., Reevaluation of Prognostic Significance of

Symptoms in Hodgkin's Disease, 56 Cancer 2874 (1985) (identifying pruritus as an

important finding in 10% of Hodgkin’s cases)). In addition to establishing pruritus

as a symptom, Gobbi et al. describe the type of itchiness as severe and resistant to

local and systemic antipruritics, which Dr. McClain found to describe the itching

Ms. Shortnacy experienced accurately. Id.

Additionally, Dr. McCabe, though not a doctor of medicine, described itchy

skin as a symptom of Hodgkin’s in a background summary of the disease compiled

from major medical journals and texts. Exhibit 13 at 3 (citing exhibits 44-49). The

literature cited by Dr. McClain and Dr. McCabe contradicts Dr. Davidson’s

implicit opinion that Ms. Shortnacy’s December 3, 2007 itching was not a

manifestation of her Hodgkin’s. Thus, a preponderance of the evidence supports a

finding that itchiness is a manifestation of Hodgkin’s.

Since Ms. Shortnacy experienced an unusual amount of itchiness the

morning of December 3, 2007, her itchiness must have begun prior to that date

because it was bothersome enough to schedule a morning appointment with Dr.

Paris.5 Exhibit 2 at 9; Findings of Fact at 7-9. Dr. McClain stated that by

December 3, 2007, Ms. Shortnacy’s itchiness had “intensified to the point where it

was a major symptom.” Exhibit B at 2. Dr. McClain’s inference is persuasive and

suggests that Ms. Shortnacy’s itchiness began some time prior to her appointment.

See exhibit 4 at 9 (February 20, 2008 statement that Ms. Shortnacy had “severe

itching, November 2007”); Second Amended Ex. 2 at 7 (March 11, 2008 letter,

stating “[a]t Thanksgiving 2007, [Ms. Shortnacy] noticed swelling in her leck neck

area. She also developed pruritus”). Thus, Ms. Shortnacy’s itchiness began before

December 2, 2007.

5

In her motion, Ms. Shortnacy cites only to a portion of her hearing testimony in which

she stated that the itchiness began after Christmas. Pet’r’s Mot. at 2 (citing Tr. 26-28, 47-48).

But, this testimony was not accepted in the ruling finding facts which determined that Ms.

Shortnacy experienced an unusual amount of itchiness on December 3, 2007. See Findings of

Fact, issued Mar. 30, 2012, at 7.

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Because Ms. Shortnacy experienced her first manifestation of Hodgkin’s

(extreme itchiness and swollen lymph nodes) more than 36 months before she filed

her petition, Ms. Shortnacy’s petition was filed outside of the statute of

limitations.6 This finding means that she is not entitled to compensation.

IV. Causation

Even if Ms. Shortnacy filed her petition within the time permitted by the

statute of limitations, she has another hurdle. To receive compensation under the

National Vaccine Injury Compensation Program, a petitioner must prove either 1)

that she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury

Table – corresponding to the HPV vaccine, or 2) that she suffered an injury that

was actually caused by a vaccine. See §§ 300aa—13(a)(1)(A) and 300aa—

11(c)(1). An examination of the record did not uncover any evidence that Ms.

Shortnacy suffered a “Table Injury.”7 Further, Ms. Shortnacy does not argue that

her Hodgkin’s was significantly aggravated by the HPV vaccines.

The elements of Ms. Shortnacy’s case were set forth by the Federal Circuit:

“(1) a medical theory causally connecting the vaccination and the injury; (2) a

logical sequence of cause and effect showing that the vaccination was the reason

for the injury; and (3) a showing of a proximate temporal relationship between

vaccination and injury.” Althen v. Sec'y of Health & Human Servs., 418 F.3d

1274, 1278 (Fed. Cir. 2005). The burden of proof is preponderance of the

evidence. Id.

Under the Act, petitioners may not be awarded compensation based solely

on the petitioner’s claims alone. Rather, the petitioner’s claims must be supported

by either medical records or by medical opinion. 42 U.S.C. § 300aa--13(a)(1).

Ms. Shortnacy relies on the opinion of Dr. McCabe. Pet’r’s Mot., citing exhibits

13, 33, 43.8 The Secretary relies on the opinion of Dr. McClain. Resp’t’s Resp.,

citing exhibits B, E, EE.

6

Ms. Shortnacy has not claimed the she is entitled to equitable tolling of the statute of

limitations.

7

No injuries are associated with any HPV vaccine. See 42 C.F.R. § 100.3.

8

Dr. Davidson has not expressed an opinion that the HPV vaccine caused Ms.

Shortnacy’s Hodgkin’s.

13

In weighing the persuasiveness of opinion testimony, special masters may

consider the background of the person offering the opinion. See Snyder v. Sec'y of

Health & Human Servs., 553 F. App'x 994, 1000-02 (Fed. Cir. 2014) (special

master’s finding that respondent’s experts were more persuasive due in part to their

current practice in neurology compared to petitioner’s expert who had no recent

practice was not arbitrary or capricious); see also Locane v. Sec’y of Health &

Human Servs., 99 Fed. Cl. 715, 727 (2011), aff’d, 685 F.3d 1375 (Fed. Cir. 2012).

Dr. McCabe’s academic background has focused on topics other than

diseases of the human lymph system. Dr. McCabe earned his Ph.D. in

Microbiology and Immunology from Albany Medical College in 1991. He

completed his postdoctoral research with the Karolinska Institute in Stockholm,

Sweden in 1992, and then taught as an assistant professor at Wayne State

University where he later served as the director of the school’s flow cytometry

center. Exhibit 13 at 2. Since 2000, Dr. McCabe has taught and conducted

research “centered on mechanistic metal toxicology and immunotoxicology” at the

University of Rochester School of Medicine and Dentistry. Id. at 1. As an

associate and (later) adjunct professor in Rochester’s Department of Environmental

Medicine, Dr. McCabe has taught courses in metal toxicity, cell signaling,

immunity, and ethics. Dr. McCabe has been a contributing author on

approximately 40 peer-reviewed publications, many relating to the toxicity of

metals. Dr. McCabe was the lead author on approximately 13 of these

publications. Exhibit 13 at 18-21.

In 2009, Dr. McCabe joined Robson Forensic, Inc., where he is currently

employed. At Robson, Dr. McCabe provides “technical investigations, analysis,

reports, and testimony toward the resolution of commercial and personal injury

litigation of toxicology” and “human health assessments” involving environmental

and occupational exposures to metals, solvents and other agents. Id. at 1.9 Dr.

McCabe’s reports linking HPV vaccine to Hodgkin’s appear to flow exclusively

from his work as a professional testifying expert. 10 Nothing in his curriculum

9

Dr. McCabe’s CV does not indicate any vaccine related “agents” in the list of human

health assessments he conducts through Robson Forensic, Inc.

10

The fact that Dr. McCabe’s income is nearly completely derived from providing expert

opinions has factored into assessments of his reliability. Godfrey v. Sec'y of Health & Human

Servs., 10-565V, 2014 WL 3058353, at *22 (Fed. Cl. Spec. Mstr. June 11, 2014). Trial judges

may apply the Daubert factors more rigorously when evaluating “for hire” experts. Johnson v.

(…continued)

14

vitae indicates that he studied Hodgkin’s or related diseases previously. See

exhibit 13.

Dr. McClain received his Ph.D. (1971) and M.D. (1972) from the University

of Chicago School of Medicine. He completed his residency at The Johns Hopkins

Hospital in Baltimore, MD in 1976. Exhibit C at 1.

Dr. McClain has coauthored more than195 peer-reviewed articles, in 80 of

which he was the primary author. Notably, Dr. McClain authored several

“UpToDate” physician’s reference articles including coauthoring the 2003

Hodgkin’s Diseases article. Exhibit C at 22. Dr. McClain has received millions of

dollars in research funding from sources such as the National Institutes of Health

and the National Cancer Institute for his work in Langerhan’s cell histiocytosis.11

Id. at 5-9. He has lectured internationally on Hodgkin’s (exhibit C at 45) and is a

tenured professor in the Department of Pediatrics at Baylor College of Medicine

and Director of the Histiocytosis Program at Texas Children’s Cancer and

Hematology Centers (exhibit C at 1, 3). Dr. McClain is currently practicing and

has more than 34 years of experience caring for children with lymphomas and

lymphoproliferative diseases caused by the Epstein Barr Virus. Exhibit B at 1-2.

Here, the difference in background is vast. Although Dr. McCabe has a

background in toxicology, he is not a medical doctor. Exhibit 13. Dr. McClain,

however, is an award-winning medical doctor who specializes in treating

lymphoma. Exhibit C.

The difference in experience is reflected in the reports from the experts. The

Secretary’s expert, Dr. McClain, wrote reports that are among the best the

undersigned has reviewed. The multitude of citations to peer-reviewed articles

reflects an intimate familiarity with the subject of lymphomas, commensurate with

more than three decades of work in the field of pediatric cancers. He is truly an

expert, a source of information to other doctors treating patients.

Manitowoc Boom Trucks, Inc., 484 F.3d 426, 435 (6th Cir. 2007) (citing Daubert v. Merrell

Dow Pharm., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995)).

11

Langerhan’s cells are antigen-presenting cells found in the lymph nodes, among other

places. Dorland’s at 320. Langerhan’s cell histiocytosis is defined as a malignancy-like

overgrowth of Langerhan’s cells. Robert M. Kliegman et al., Nelson Textbook of Pediatrics

1773 (19th ed. 2011).

15

In contrast, Ms. Shortnacy’s expert, Dr. McCabe, qualifies as an expert in

immunology on the basis of his Ph.D. and career experience, which has focused

mainly on toxicological effects of metals. He has been found qualified to opine

about immunology and toxicity of metals. Koehn v. Sec'y of Health & Human

Servs., 11-355V, 2013 WL 3214877, at *32 (Fed. Cl. May 30, 2013), mot. for

review denied sub nom. C.K. v. Sec'y of Health & Human Servs., 113 Fed. Cl. 757

(2013), appeal docketed, No. 14-5054 (Fed. Cir. Feb. 18, 2014); Snyder v. Sec'y of

Health & Human Servs., 01-162V, 2009 WL 332044, at *19 (Fed. Cl. Spec. Mstr.

Feb. 12, 2009), mot. for review denied, 88 Fed. Cl. 706 (2009); Hazlehurst v. Sec'y

of Health & Human Servs., 03-654V, 2009 WL 332306, at *11 (Fed. Cl. Spec.

Mstr. Feb. 12, 2009), mot. for review denied, 88 Fed. Cl. 473 (Fed. Cl. 2009),

aff’d, 604 F.3d 1343 (Fed. Cir. 2010). But, in offering an opinion that a vaccine

can and did cause a lymphoma, Dr. McCabe is leaving the fields of science where

he is most knowledgeable.

Dr. McCabe’s reports illustrate his relative lack of knowledge about

lymphomas. Although Dr. McCabe cited articles throughout his reports, Dr.

McClain has persuasively shown that Dr. McCabe took passages out of context and

did not fully appreciate the nuances of the studies.

Flaws in Dr. McCabe’s reports are apparent in all the Althen prongs. The

first Althen prong asks whether the vaccine could cause the alleged injury. See

Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed. Cir. 2006)

(affirming special master’s use of “can cause” and “did cause” as consistent with

the Althen test); Veryzer v. Sec'y of Health & Human Servs., 100 Fed. Cl. 344, 352

(2011) (describing the first prong of Althen as presenting the question of general

causation). Dr. McCabe’s reports are convoluted and not easily summarized, but,

essentially, he argues that the HPV vaccine causes the proliferation and survival of

initiated HRS precursors which results in the proliferation of Hodgkin’s

lymphoma. Pet’r’s Prehr’g Br. at 11 (citing exhibit 33 at 2).

But, Dr. McClain contradicts this postulate and asserts that it is “not

scientifically reliable.” Exhibit BB at 1. According to Dr. McClain, Ms.

Shortnacy’s Hodgkin’s was a result of genetic mutations arising in her germinal B

cells independent of vaccination and that these mutations forestalled the immune

signals implicated in Dr. McCabe’s theory. Id. at 2; exhibit E at 3-4. Dr. McClain

challenged Dr. McCabe’s claim that HPV vaccine could cause HRS cell

proliferation since these cells lack functional genes necessary for such stimulation.

Exhibit E at 3. Moreover, Dr. McClain summarily showed that Dr. McCabe’s

claim of EBV involvement was an incorrect assumption given current literature

16

and available laboratory analysis of Ms. Shortnacy’s biopsy. Exhibit E at 3 (citing

exhibit X (Tiacci)). Dr. McClain’s awareness regarding EBER staining is also

telling of his greater familiarity of the subject matter.

Another deficiency in Dr. McCabe’s report is his opinion regarding timing,

which corresponds to the third Althen prong.12 Ms. Shortnacy must show that the

first manifestation of her Hodgkin’s occurred in a medically appropriate timeframe

to infer causation. Dr. McCabe provided a vague opinion on timing stating that

“the expected interval between vaccination and the onset of HL is predicted by the

time period that measur[]able changes in the immune response are known to be

elicited by the vaccine.” Exhibit 33 at 2-3. Dr. McCabe cited to the time points

used by Frazer and Pinto to define the “time period” of HPV elicited immune

response during which Hodgkin’s might arise. Dr. McCabe estimated that

increased cytokine production occurred up to seven months following vaccination.

Id. (citing exhibit 34 (Frazer); exhibit 35 (Pinto)). However, Dr. McClain

persuasively showed that Dr. McCabe misinterpreted the Frazer and Pinto studies

such that they did not support Dr. McCabe’s assumption regarding increased

cytokine production up to seven months following vaccination. Exhibit BB at 2-3.

On the remaining Althen prong, Ms. Shortnacy’s evidence is similarly

unimpressive. The second Althen prong requires Ms. Shortnacy to establish by

preponderant evidence “a logical sequence of cause and effect” showing that the

HPV vaccine caused her Hodgkin’s. Althen, 418 F.3d at 1274. Factors that can

make Ms. Shortnacy’s case “logical” include evidence showing that her Hodgkin’s

arose by the means predicted by her expert’s theory and the views of her treating

physicians. LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1340

(Fed. Cir. 2014) (special master did not err in requiring some proof that petitioner’s

theory actually explained petitioner’s injury) (citing Hibbard v. Sec'y of Health &

Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (petitioner required to show

both the likelihood of her theory of causation and that the alleged injury was

consistent with that theory)); Moberly, 592 F.3d at 1324-25.

Dr. McCabe suggested that Ms. Shortnacy’s previously observed titers for

EBV may have played a role in facilitating the HPV vaccination in causing

Hodgkin’s. Exhibit 13 at 4-5. However, the EBER testing done at Dr. McClain’s

suggestion showed that no EBV was present in Ms. Shortnacy’s biopsy. See

12

Dr. McCabe has had previous trouble establishing the third prong of Althen. See

Koehn, 2013 WL 3214877, at *32; see also Godfrey, 2014 WL 3058353, at *23.

17

exhibit 42; see also exhibit E at 3; exhibit EE. Ms. Shortnacy has not provided

other evidence that the remainder of Dr. McCabe’s theory was likely at work in

causing her Hodgkin’s.

In sum, Ms. Shortnacy has not demonstrated the persuasiveness of Dr.

McCabe’s opinion regarding any Althen prong. On the simplest level, Dr. McCabe

is much, much less knowledgeable about Hodgkin’s than Dr. McClain. Ms.

Shortnacy has presented no persuasive reason that her expert, who has never

studied Hodgkin’s, should be credited over the Secretary’s expert, who is probably

among this country’s most knowledgeable doctors on Hodgkin’s.

V. Conclusion

Ms. Shortnacy seeks compensation in the Vaccine Program alleging that the

HPV vaccines she received caused her Hodgkin’s disease. Ms. Shortnacy has

failed to demonstrate by a preponderance of the evidence that the onset of her

Hodgkin’s occurred within the time allowed under the statute of limitations or that

her Hodgkin’s was caused-in-fact by the HPV vaccines she received.

Consequently, she is not entitled to compensation.

The Clerk’s Office is instructed to issue judgment in accord with this

decision.

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master

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